New BRIUMVI® (ublituximab-xiiy) Data from the ENHANCE Phase 3b Study Show Rapid 30-Minute Infusions are Well Tolerated in Patients with Relapsing Forms of Multiple Sclerosis
TG Therapeutics (NASDAQ: TGTX) presented updated data from the ENHANCE Phase 3b trial of BRIUMVI® (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS) at the 2024 ECTRIMS meeting. Key findings include:
1. Patients switching from prior anti-CD20 treatment can successfully eliminate the initial BRIUMVI infusion.
2. Rapid 30-minute BRIUMVI infusions are well-tolerated, with only mild (Grade 1) infusion-related reactions.
3. 97% of 1-hour infusions for B-cell depleted patients were completed without interruption.
4. 12 patients received 30-minute infusions at week 24, all completed without interruption.
The company aims to improve patient tolerability and convenience, potentially leading to label-enabling studies for optimized dosing regimens.
TG Therapeutics (NASDAQ: TGTX) ha presentato dati aggiornati dallo studio ENHANCE Phase 3b su BRIUMVI® (ublituximab-xiiy) per le forme recidivanti della sclerosi multipla (RMS) durante l'incontro ECTRIMS 2024. I risultati chiave includono:
1. I pazienti che passano da un trattamento anti-CD20 precedente possono eliminare con successo l'infusione iniziale di BRIUMVI.
2. Le infusioni rapide di BRIUMVI della durata di 30 minuti sono ben tollerate, con solo lievi reazioni legate all'infusione (Grado 1).
3. Il 97% delle infusioni di 1 ora per pazienti con deplezione delle cellule B sono state completate senza interruzione.
4. 12 pazienti hanno ricevuto infusioni di 30 minuti alla settimana 24, tutte completate senza interruzione.
L'azienda mira a migliorare la tollerabilità e la comodità per i pazienti, potenzialmente portando a studi abilitanti per l'etichetta riguardo ai regimi di dosaggio ottimizzati.
TG Therapeutics (NASDAQ: TGTX) presentó datos actualizados del ensayo ENHANCE Phase 3b de BRIUMVI® (ublituximab-xiiy) para las formas recidivantes de esclerosis múltiple (RMS) en la reunión ECTRIMS 2024. Los hallazgos clave incluyen:
1. Los pacientes que cambian de un tratamiento previo anti-CD20 pueden eliminar con éxito la infusión inicial de BRIUMVI.
2. Las infusiones rápidas de BRIUMVI de 30 minutos son bien toleradas, con solo reacciones leves (Grado 1) relacionadas con la infusión.
3. El 97% de las infusiones de 1 hora para pacientes con depleción de células B se completaron sin interrupción.
4. 12 pacientes recibieron infusiones de 30 minutos en la semana 24, todas completadas sin interrupción.
La empresa busca mejorar la tolerancia y comodidad del paciente, lo que podría llevar a estudios de habilitación de etiquetado para regímenes de dosificación optimizados.
TG Therapeutics (NASDAQ: TGTX)는 2024 ECTRIMS 회의에서 반복형 다발성 경화증 (RMS)을 위한 BRIUMVI® (ublituximab-xiiy) ENHANCE Phase 3b 시험의 업데이트된 데이터를 발표했습니다. 주요 발견은 다음과 같습니다:
1. 이전의 항-CD20 치료에서 전환하는 환자들이 초기 BRIUMVI 주입을 성공적으로 제거할 수 있습니다.
2. 30분 간의 빠른 BRIUMVI 주입은 잘 견디며, 경미한(Grade 1) 주입 관련 반응만 나타났습니다.
3. B세포가 고갈된 환자에 대한 1시간 주입의 97%가 중단 없이 완료되었습니다.
4. 24주 차에 30분 간의 주입을 받은 12명의 환자 모두 중단 없이 완료되었습니다.
회사는 환자의 견딜 수 있는 능력과 편리함을 개선하는 것을 목표로 하며, 최적의 용량 요법을 위한 라벨 승인 연구로 이어질 수 있습니다.
TG Therapeutics (NASDAQ: TGTX) a présenté des données actualisées de l'essai ENHANCE Phase 3b concernant BRIUMVI® (ublituximab-xiiy) pour les formes récurrentes de sclérose en plaques (RMS) lors de la réunion ECTRIMS 2024. Les principales conclusions comprennent :
1. Les patients passant d'un traitement anti-CD20 précédent peuvent éliminer avec succès l'infusion initiale de BRIUMVI.
2. Les infusions rapides de BRIUMVI de 30 minutes sont bien tolérées, n'entraînant que des réactions légères (Grade 1) liées à l'infusion.
3. 97 % des infusions d'une heure pour les patients dont les cellules B ont été épuisées ont été réalisées sans interruption.
4. 12 patients ont reçu des infusions de 30 minutes à la semaine 24, toutes complètes sans interruption.
L'entreprise vise à améliorer la tolérance et le confort des patients, ce qui pourrait conduire à des études favorables à l'étiquetage pour des schémas de dosage optimisés.
TG Therapeutics (NASDAQ: TGTX) präsentierte aktualisierte Daten aus der ENHANCE Phase 3b Studie zu BRIUMVI® (ublituximab-xiiy) für rezidivierende Formen von Multipler Sklerose (RMS) auf der ECTRIMS 2024 Konferenz. Wichtige Ergebnisse umfassen:
1. Patienten, die von einer vorherigen Anti-CD20-Behandlung wechseln, können die erste BRIUMVI-Infusion erfolgreich eliminieren.
2. Schnelle 30-minütige BRIUMVI-Infusionen werden gut vertragen, mit nur milden (Grad 1) infusionsbedingten Reaktionen.
3. 97% der 1-stündigen Infusionen für bei B-Zellen depletierten Patienten wurden ohne Unterbrechung abgeschlossen.
4. 12 Patienten erhielten 30-minütige Infusionen in Woche 24, alle wurden ohne Unterbrechung abgeschlossen.
Das Unternehmen zielt darauf ab, die Verträglichkeit und Bequemlichkeit für die Patienten zu verbessern, was möglicherweise zu etikettierfähigen Studien zu optimierten Dosierungsregimen führen könnte.
- Successful elimination of initial 150 mg, 4-hour BRIUMVI infusion for patients switching from prior anti-CD20 therapy
- Well-tolerated 30-minute rapid infusions with only mild (Grade 1) reactions
- 97% of 1-hour infusions completed without interruption for B-cell depleted patients
- All 12 patients receiving 30-minute infusions at week 24 completed without interruption
- Potential for improved patient convenience and tolerability with shorter infusion times
- None.
Insights
The ENHANCE Phase 3b trial results for BRIUMVI® (ublituximab-xiiy) in relapsing multiple sclerosis (RMS) patients are promising. The data shows that 30-minute infusions are well-tolerated, with only mild Grade 1 infusion-related reactions that resolved completely. This is a significant improvement in treatment administration, potentially reducing patient burden and healthcare resource utilization.
Moreover, the study demonstrates that patients can successfully switch from prior anti-CD20 treatments to BRIUMVI without the initial 150 mg, 4-hour infusion. This streamlined transition could enhance treatment flexibility and patient convenience. The ability to administer full 450 mg doses in just 30 minutes, without drowsy pre-medications or post-infusion observation, represents a notable advancement in MS treatment protocols.
TG Therapeutics' (NASDAQ: TGTX) BRIUMVI® optimization study results could significantly impact the company's market position. The potential for faster infusions and simplified treatment protocols may enhance BRIUMVI's competitive edge in the crowded MS market. This could lead to increased adoption rates and market share gains, potentially boosting revenue growth.
Furthermore, the ability to transition patients from other anti-CD20 therapies more easily could facilitate market penetration. While specific financial projections aren't provided, these advancements could positively influence TGTX's long-term profitability. Investors should monitor how these clinical improvements translate into commercial success and impact the company's financial performance in upcoming quarters.
Infusion related reactions in patients receiving 30-minute BRIUMVI infusions were all mild (Grade 1) and resolved completely
Data also demonstrate patients switching from prior anti-CD20 treatment can successfully eliminate initial BRIUMVI infusion
NEW YORK, Sept. 18, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today presented updated data from the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting. Highlights from the presentation are outlined below.
Michael S. Weiss, the Company’s Chairman and Chief Executive Officer stated, “We are excited to present an update from our ENHANCE Phase 3b study which is evaluating potential optimized dosing regimens for BRIUMVI. This study initially focused on patients switching from a prior anti-CD20 therapy in a B-cell depleted state, and we believe the data emerging from this study continues to support that these patients can successfully make that transition conveniently and safely without the initial 150 mg, 4-hour BRIUMVI infusion.” Mr. Weiss continued, “Separately, we are excited to present, for the first time, data exploring even faster infusions of BRIUMVI, from 1 hour down to 30 minutes for full doses starting at week 24. Notably, these rapid infusions are being accomplished with non-drowsy pre-medications and no required post-infusion observation time as per the protocol, consistent with the BRIUMVI prescribing information. We look forward to continuing to find ways to improve patient tolerability and convenience and working with regulatory agencies to transition these efforts into label-enabling studies.”
DATA HIGHLIGHTS:
Poster Presentation: Efficacy and Tolerability of BRIUMVI (ublituximab) after Transitioning from a Different Disease-Modifying Therapy: Updates from the ENHANCE Study
- ENHANCE is a multi-center, open-label, 48-week study in participants with relapsing forms of multiple sclerosis (RMS) designed to evaluate optimized dosing regimens for BRIUMVI with two primary objectives:
- Evaluating the elimination of the initial 150 mg BRIUMVI infusion in patients who are B-cell depleted
- Exploring shorter infusion durations for the full 450 mg BRIUMVI infusions
- Data continue to support that 450 mg of BRIUMVI may be safely administered in 1 hour as an initial infusion for participants who are B-cell depleted, with
97% of infusions being completed without interruption or slowing - 12 patients received 450 mg BRIUMVI infusions in 30 minutes at week 24, with all infusions completed without interruption or slowing, and infusions related reactions (IRRs) were limited to Grade 1 (n=2)
The data presentation is also available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.
ABOUT THE ULTIMATE I & II PHASE 3 TRIALS
ULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University. Additional information on these clinical trials can be found at http://www.clinicaltrials.gov (NCT03277261; NCT03277248).
ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.
BRIUMVI is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
A list of authorized specialty distributors can be found at www.briumvi.com.
IMPORTANT SAFETY INFORMATION
Contraindications: BRIUMVI is contraindicated in patients with:
- Active Hepatitis B Virus infection
- A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS
Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was
Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.
Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was
Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.
Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for surface premedantigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.
Progressive Multifocal Leukoencephalopathy (PML): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies.
If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.
If PML is confirmed, treatment with BRIUMVI should be discontinued.
Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.
Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.
Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.
Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in
Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least
Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.
ABOUT BRIUMVI PATIENT SUPPORT
BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.
ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately
ABOUT TG THERAPEUTICS
TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit www.tgtherapeutics.com, and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn.
BRIUMVI® is a registered trademark of TG Therapeutics, Inc.
Cautionary Statement
This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below.
Such forward looking statements include but are not limited to statements regarding the results of the ULTIMATE I & II Phase 3 studies, the ENHANCE Phase 3b study, and BRIUMVI as a treatment for relapsing forms of multiple sclerosis (RMS). Additional factors that could cause our actual results to differ materially include the following: the risk that the data from the ULTIMATE I & II and its Open-Label Extension (OLE) or ENHANCE trials that we announce or publish may change, or the product profile of BRIUMVI may be impacted, as more data or additional endpoints are analyzed; the risk that the dose-optimization efforts being undertaken in ENHANCE will not transition into label-enabling studies, or that any label-enabling efforts may be unsuccessful; the risk that data may emerge from future clinical studies or from adverse event reporting that may affect the safety and tolerability profile and commercial potential of BRIUMVI; the risk that any individual patient’s clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that BRIUMVI will not be commercially successful; our ability to expand our commercial infrastructure, and successfully market and sell BRIUMVI in RMS; the Company’s reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements; the uncertainties inherent in research and development; and general political, economic and business conditions, including the risk that the ongoing COVID-19 pandemic could have on the safety profile of BRIUMVI and any of our other drug candidates as well as any government control measures associated with COVID-19 that could have an adverse impact on our research and development plans or commercialization efforts. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in our other filings with the U.S. Securities and Exchange Commission.
Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
CONTACT:
Investor Relations
Email: ir@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 4
Media Relations:
Email: media@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 6
1. MS Prevalence. National Multiple Sclerosis Society website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor p. 236.
FAQ
What were the key findings of the BRIUMVI ENHANCE Phase 3b study presented at ECTRIMS 2024?
How does the ENHANCE study aim to optimize BRIUMVI dosing for multiple sclerosis patients?
What is the significance of the 30-minute BRIUMVI infusions in the ENHANCE study?
How might the ENHANCE study results impact future BRIUMVI treatment protocols for multiple sclerosis?
